Growth Hormone Use in Adults With Prader-Willi Syndrome

Completed · Phase 3

Conditions studied: Prader-Willi Syndrome

In brief

The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months.

Key facts

Study ID

NCT00444964

Run by

Children's Mercy Hospital Kansas City

People needed

11

Starts

2005-04-01

Expected to finish

2012-01-01

Last updated by the study team

2021-01-08

Who can join

Age: 16 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 16 to 60 years old
• Male or female with diagnosed Prader-Willi syndrome confirmed by genetic testing (e.g., mPCR)
• Low IGF-1 level (e.g.,≤25%) at baseline
• Ability to provide informed consent or availability of a suitable legally authorized representative

You may not qualify if…

• Pregnancy
• Previous treatment with growth hormone
• Uncontrolled endocrine disease, (i.e. diabetes or thyroid)
• History of severe scoliosis
• Heart disease
• Uncontrolled high blood pressure or history of stroke
• Morbid obesity (using PWS growth charts)
• Severe sleep apnea or known breathing difficulties/obstruction (as per history or diagnostic testing results

Where it is running

• The Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.